DESCRIPTION (provided by applicant): The objective of this proposal is the development, evaluation and validation of an accurate, low cost diagnostic test that can discriminate prostate cancer from benign prostatic hyperplasia to a Specificity of 85% at aSensitivity of 85%. Prostate cancer is the most common cancer in men, with a probability of 1 in 6. Approximately 29% of all cancer cases in males are prostate cancer with 27,050 deaths estimated in 2009. As in most cancers, early and accurate detectioncan be life saving. However, a major deficiency of the current prostate cancer screening test, PSA, is that it does not discriminate between cancer and a common benign condition; benign prostatic hyperplasia (BPH). In fact, 88% of positive PSA tests are attributed to BPH. Although BPH is a non-threatening condition, only expensive biopsies can distinguish it from prostate cancer. Technological Innovation. Inanovate has partnered with investigators at Brigham and Women's Hospital (BWH) to identify a seriesof auto-antibody biomarkers capable of distinguishing prostate cancer from BPH to a Specificity of 85% at a Sensitivity of 85%. The proposed diagnostic test integrates this biomarker panel with a novel biochip platform capable of accurately screening multiple low concentration proteins from blood samples at the point of care. The platform includes a nano-particle surface technology that improves assay sensitivity by controlling the distribution and orientation of proteins across the biochip surface; and areal-time fluorescent biochip scanner and analysis methodology that enables the discrimination of 'specific' (true) biomarker signals from 'non-specific' (false) signals. Phase I Summary. The objective was to demonstrate the feasibility of using a nano-particle biochip surface technology in combination with real-time florescent imaging to measure the concentration of multiple autoantibody biomarkers for accurate detection of prostate cancer. In Phase I a prototype system was developed and tested. Followingreviewer critiques from the original Phase II submission, the prototype platform has been substantially re-engineered, and the performance significantly improved. Through Phase II, this system will be advanced for point-of-care (PoC) use, in parallel withvalidation of the auto-antibody biomarker panel in preparation for multi-site clinical trials. Phase II Objectives. 1) Develop PoC version of the real-time flow-based screening platform, 2) Validate biomarkers using real-time measurement, 3) Prepare regulatory/commercial plans for clinical trials. Commercial Opportunity. The potential market for a point-of-care prostate cancer screening is estimated at over 2B p.a. Furthermore, by helping make accurate cancer screening available and affordable to everyone, we see the underlying diagnostic platform proposed herein playing a key role in moving the health industry's focus away from inefficient late stage treatments, towards early stage diagnosis and lower cost therapies. PUBLIC HEALTH RELEVANCE: The most common cancer in men is prostate cancer, with a lifetime probability of 1 in 6. Approximately 200,000 new cases of prostate cancer are diagnosed per year with nearly 30,000 deaths. The current FDA approved diagnostic test for prostate cancer (PSA)has a limitation in that serum levels of PSA are elevated in both prostate cancer and Benign Prostatic Hyperplasia (BPH). Most men with an elevated PSA level turn out to not have cancer; with unnecessary biopsies performed in as many as 88% of men (over1 million each year) at a cost of 2 billion p.a. to the US health system. A low cost test which can accurately distinguish prostate cancer from BPH is critically needed.